NeurAxis Announces Results of Comparative Study of IB-Stim™ and Standard Medical Therapy in Adolescents with Functional Abdominal Pain Disorders
September 26 2023 - 9:00AM
NeurAxis, Inc. (“NeurAxis,” or the “Company”) (NYSE American:
NRXS), a medical technology company commercializing neuromodulation
therapies that address chronic and debilitating conditions in
children and adults, today announced the results of a retrospective
comparative study of adolescent patients with functional abdominal
pain disorders (FAPD) treated with IB-Stim™ therapy or standard of
care medications, amitriptyline (tricyclic antidepressant) or
cyproheptadine (antihistamine). Led by the Cincinnati Children’s
Hospital Medical Center, the comparative study concluded that
IB-Stim™ may be a good non-pharmacologic alternative for FAPD.
The publication, Percutaneous electrical nerve
field stimulation compared to standard medical therapy in
adolescents with functional abdominal pain disorders, featured in
the September 19th 2023 Frontiers in Pain Research, reviewed
records of 101 adolescents treated with 4 weeks of IB-Stim™,
amitriptyline or cyproheptadine. In the study, 59% of patients in
the IB-Stim group had failed prior standard medical therapy.
Evaluated outcome measures included validated pediatric
questionnaires using Abdominal Pain Index (API), Nausea Severity
Scale (NSS) and Functional Disability Inventory (FDI) at baseline
and at 3-month follow up. The comparative analysis noted that:
- at follow up, IB-Stim™ therapy showed improvements in abdominal
pain (p=0.001) and functional disability (p=0.048) compared to
baseline, while amitriptyline showed improvements in abdominal pain
(p=0.034);
- in a comparison of outcomes between groups, IB-Stim™ was more
effective than cyproheptadine in improving abdominal pain (p=0.04)
and did not differ from amitriptyline (p=0.64). Nausea scores did
not differ between groups (p>0.05); and
- disability scores between groups were only more effective for
amitriptyline vs. cyproheptadine (p=0.03). Disability scores did
not differ from amitriptyline compared with IB-Stim™ (p=0.21).
Dr. Adrian Miranda, Chief Medical Officer of
NeurAxis, said, “It is exciting to see a comparative evaluation of
IB-Stim™ with standard medical therapy. Although amitriptyline and
cyproheptadine are amongst the most commonly used medications to
treat functional abdominal pain, there is a lack of clinical
evidence for using these medications in children and it may be that
these medications just don’t perform as well as we think”. Dr.
Miranda added, “it is difficult to know how a drug will perform in
the real world, even after a positive clinical trial, because drugs
are metabolized differently. This is one of the reasons drug trials
need to be very large. More importantly, side effects need to be
monitored closely, particularly in children. Nonetheless, we are
pleased that IB-Stim™ continues to show positive clinical results
with minimal to no side-effects, making it an effective FAPD
treatment option.”
Forward-Looking
StatementsCertain statements in this press release are
forward-looking statements within the meaning of Section 27A of the
Securities Act of 1933, as amended, and Section 21E of the
Securities Exchange Act of 1934, as amended. All statements other
than statements of historical fact are forward-looking statements.
Forward-looking statements are based on management’s current
assumptions and expectations of future events and trends, which
affect or may affect the Company’s business, strategy, operations
or financial performance, and actual results and other events may
differ materially from those expressed or implied in such
statements due to numerous risks and uncertainties. Forward-looking
statements are inherently subject to risks and uncertainties, some
of which cannot be predicted or quantified. There are a number of
important factors that could cause actual results, developments,
business decisions or other events to differ materially from those
contemplated by the forward-looking statements in this press
release. These factors include, among other things, the conditions
in the U.S. and global economy, the trading price and volatility of
the Company’s stock, public health issues or other events, the
Company’s compliance with applicable laws, the results of the
Company’s clinical trials and perceptions thereof, as well as
factors described in the Risk Factors section of NeurAxis’s public
filings with the Securities and Exchange Commission (SEC). Because
forward-looking statements are inherently subject to risks and
uncertainties, you should not rely on these forward-looking
statements as predictions of future events. These forward-looking
statements speak only as of the date of this press release and,
except to the extent required by applicable law, the Company
undertakes no obligation to update or revise these statements,
whether as a result of any new information, future events and
developments or otherwise.
About NeurAxis, Inc.NeurAxis,
Inc., is a medical technology company focused on neuromodulation
therapies to address chronic and debilitating conditions in
children and adults. NeurAxis is dedicated to advancing science and
leveraging evidence-based medicine to drive adoption of its
IB-Stim™ therapy, which is its proprietary Percutaneous Electrical
Nerve Field Stimulation (PENFS) technology, by the medical,
scientific, and patient communities. IB-Stim™ is FDA cleared for
functional abdominal pain associated with irritable bowel syndrome
(IBS) in adolescents 11-18 years old. Additional clinical trials of
PENFS in multiple pediatric and adult conditions with large unmet
healthcare needs are underway. For more information, please visit
http://neuraxis.com/.
This page discusses ongoing research activities
with percutaneous electrical nerve field stimulator (PENFS)
technology. Please note, the research being described includes
information about technology and intended uses of that technology
which have not been reviewed or approved/cleared by the U.S. FDA,
and is being provided for informational purposes only. NeurAxis
does not recommend or suggest the use of its PENFS IB-Stim™ device
for uses beyond those that are cleared by the U.S. FDA. See
https://ibstim.com/important-information/.
Contacts:
CompanyNeurAxis,
Inc.info@neuraxis.com
Investor
RelationsGilmartin
GroupIR@neuraxis.com
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